Pharmaceutical Trials Audit Form
Document and assess compliance, quality, and procedures at clinical trial sites.
Site Name and Location
*
Date of Audit
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Auditor Name and Role
*
First Name
Last Name
Trial Protocol Number or Title
*
Type of Audit
*
Routine
For Cause
Close-Out
Other
Protocol Compliance Assessment
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Informed consent process followed
1
2
3
4
Eligibility criteria verified
5
6
7
8
Investigational product accountability
9
10
11
12
Safety reporting procedures
13
14
15
16
Data recording and reporting
17
18
19
20
Documentation Review
Source documents complete
Case Report Forms accurate
Regulatory binders updated
Adverse event logs maintained
Other (specify)
Facility and Equipment Assessment
*
1
2
3
4
5
Staff Qualifications and Training Records Verified
*
Yes
No
Partially
Summary of Findings and Observations
*
Recommended Corrective Actions
Submit Audit
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